Study of the safety & effectiveness of JNJ-56136379 in hepatitis B
Research type
Research Study
Full title
A Phase 2a, Randomised, Partially-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of 24 Weeks of Treatment With Multiple Doses of JNJ-56136379 as Monotherapy and in Combination With a Nucleos(t)ide Analogue in Subjects With Chronic Hepatitis B Virus Infection
IRAS ID
229477
Contact name
Aleidis Lasure
Contact email
Sponsor organisation
Janssen Sciences Ireland UC
Eudract number
2017-001110-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 2 days
Research summary
The purpose of this study is to see how well and how safely a study drug (called ‘JNJ-56136379’) works in people who have hepatitis B. The study drug will be compared to a dummy drug (or ‘placebo’). This study will look at the effects of JNJ-56136379 alone and in combination with either of two drugs already approved to treat hepatitis B: entecavir (ETV) and tenofovir disoproxil fumarate (TDF). All treatments are tablets to be taken once a day. This study is made up of an 8-week screening period, a 24-week treatment period and a 24-week follow up period. At screening, participants sign an informed consent form then they undergo various tests and assessments to see if they can enter the study. These include blood tests, an electrocardiogram and procedures to look at the liver (if a participant has not had these done recently). If a participant is eligible for treatment, it will then be decided by chance which treatment they receive: JNJ-56136379 or placebo. If a participant has never received treatment for their hepatitis B (or not in the past 6 months), it will be decided by chance which of the following three treatments they will receive: JNJ-56136379 alone, JNJ-56136379 plus ETV or TDF or placebo plus ETV or TDF. There is a 6 in 7 chance that a participant will receive JNJ-56136379. If a participant is already taking ETV or TDF for their hepatitis B, they will continue to take that medicine, but will also receive either JNJ-56136379 or placebo. There is a 3 in 4 chance that they will receive JNJ-56136379. During the treatment and follow-up periods, participants will be asked to come to clinic for further tests and assessments. Participants will be continually monitored and their JNJ-56136379/placebo stopped if they are unable to tolerate any side effects.
REC name
North West - Haydock Research Ethics Committee
REC reference
18/NW/0075
Date of REC Opinion
20 Feb 2018
REC opinion
Favourable Opinion